Jim Miller, President, PharmSource Information Services, Inc., sounds as much like a travel agent as a pharma outsourcing prognosticator at his DCAT Week ’17 market overview on pharmaceutical contract development and manufacturing: Pharma’s billions for biologics are staying home; small molecules continue to hit the road.
The past few years have seen a record number of mergers and acquisitions (M&As) in the pharmaceutical industry. When a pharmaceutical company acquires or merges with another pharmaceutical company, there is already in-house expertise on all aspects of the business, and the due diligence is performed by dispatching the document reviews among the different company’s departments, i.e., finance, legal, marketing, regulatory, operations, and logistics.
A drug stability program that is above reproach is critical to successfully navigating the complexities of drug development. A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.
One week before we published the article 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance, Life Science Connect attended a thought-provoking presentation about said guidance at a local ISPE event in Philadelphia. While the article covered several key things the guidance document did communicate to industry, the ISPE presentation focused more on what the guidance document failed to say and do … and the implications of those omissions.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
By upgrading from ÄKTAexplorer to ÄKTA avant chromatography system, you can improve productivity in process development. Depending on your application and how the system is operated, different ways to improve your productivity will have varying impact. Here we show 10 ways to boost your productivity.
With things “heating up” in terms of more diverse temperature demands, the industry is moving away from the term cold chain, and we’ll start to see more references to the more inclusive temperature-controlled transport.
Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.
Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.
Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.
Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.
Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.
Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.
With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.
Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.
The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
In the pharmaceutical industry, the FDA good manufacturing practices are ever evolving, but the roots are established in 21 CFR Parts 210 & 211 (for drugs). FDA has recently began looking at quality metrics as well, and even established an Office of New Drug Quality Assessment (ONDQA) which assesses the critical quality attributes and manufacturing processes of new drugs.
In order to set up a quality organization, the organization must have a culture of quality. Survey findings in the Forbes Insights-ASQ white paper published in fall of 2014 offer research findings which help illuminate what quality culture means to organizations globally.
Name brand (Innovator) pharmaceutical companies must extend the product life cycles of drugs to maintain profits, exclusivity, market share and transition into next generation products. Patent protection is crucial to the innovative pharmaceutical industry. Innovative companies require the guaranteed period of market exclusivity to sustain drug prices, recoup research and development costs and to fund the development of new products or next generation drugs.
Pharmaceutical companies frequently ask us this question when they have a multi-dosage form portfolio they want us to provide a quotation or scope of work on. The answer to this question is multi-faceted in that there are a number of questions with regard to materials, process, and testing requirements that need to answered.
Pharmaceutical companies frequently ask us this question: how much does it cost to manufacture a pharmaceutical tablet? The real answer is: it depends on many factors. We need to truly understand the detailed specifics of the pharmaceutical company’s objectives and requirements for the product, with respect to manufacturing, packaging, testing, and regulatory submission in order for us to address cost in an intelligent and realistic manner.